Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the
Company), a biopharmaceutical company committed to delivering
therapeutics that change the trajectory of autoimmune disease,
today announced that data from multiple studies of LUPKYNIS®
(voclosporin) will be presented at the American Society of
Nephrology (ASN) Kidney Week 2022, taking place November 3-6 in
Orlando, Florida. These presentations by several leading experts in
nephrology build on the robust evidence supporting the long-term
safety and efficacy profile of LUPKYNIS for the treatment of adults
with active lupus nephritis (LN), a serious complication of
systemic lupus erythematosus (SLE).
The abstracts for ASN Kidney Week 2022 are listed below and
available online at:
https://www.asn-online.org/education/kidneyweek/2022/program-search-abstract.aspx
ASN Kidney Week 2022 Oral and Poster
Presentations:
Title: Efficacy and Safety of Voclosporin Over Three
Years in Patients with Severe Lupus Nephritis Presenting
author: Hanni Menn-Jospehy, M.D., Boston University School of
Medicine, Boston, Massachusetts Date: Friday, November 4,
2022 Time: 5:33 p.m - 5:42 p.m ET Session:
FR-OR58
Title: Enlight-LN: A Prospective Observational Registry
of Patients Treated with Voclosporin for Lupus Nephritis in the
United States Presenting author: Keith J. Tagoe, Pharm.D.,
R.Ph., Aurinia Pharmaceuticals Inc, Rockville, Maryland
Date: Thursday, November 3; Friday, November 4; Saturday,
November 5, 2022 Time: 10:00 a.m - 12:00 p.m ET
Session: INFO36
Title: Long-term Use of Voclosporin in Patients with
Class V Lupus Nephritis: Results from the AURORA 2 Continuation
Study Presenting author: Dawn Caster, M.D., University of
Louisville, Louisville, Kentucky Date: Friday, November 4,
2022 Time: 10:00 a.m - 12:00 p.m ET Session:
FR-PO640
Title: Voclosporin for Lupus Nephritis: Assessment of
Long-Term Safety and Efficacy Including Renal Outcome Over Three
Years of Treatment in the Phase 3 AURORA 1 and AURORA 2 Studies
Presenting author: Samir V. Parikh, M.D., The Ohio State
University Wexner Medical Center, Columbus, Ohio Date:
Thursday, November 3, 2022 Time: 10:00 a.m - 12:00 p.m ET
Session: TH-PO486
Title: Long-Term Safety and Efficacy Of Voclosporin in
Patients With Lupus Nephritis and Low eGFR Presenting
author: Ramesh Saxena, M.D., Ph.D., The University of Texas
Southwestern Medical Center, Dallas, Texas Date: Thursday,
November 3, 2022 Time: 10:00 a.m - 12:00 p.m ET
Session: TH-PO488 Title: Voclosporin Therapy Induces
Systemic Lipidomic Alterations: Implications for Lipid Mediators
for Remission of Lupus Nephritis
Presenting author: Farsad Afshinnia, M.D., University of
Michigan, Ann Arbor, Michigan Date: Saturday, November 5,
2022 Time: 10:00 a.m - 12:00 p.m ET Session:
SA-PO688
About Lupus Nephritis
LN is a serious manifestation of SLE, a chronic and complex
autoimmune disease. About 200,000-300,000 people live with SLE in
the U.S. and about one-third of these people are diagnosed with
lupus nephritis at the time of their SLE diagnosis. About 50
percent of all people with SLE may develop lupus nephritis. If
poorly controlled, LN can lead to permanent and irreversible tissue
damage within the kidney. Black and Asian individuals with SLE are
four times more likely to develop LN and individuals of Hispanic
ancestry are approximately twice as likely to develop the disease
when compared with Caucasian individuals. Black and Hispanic
individuals with SLE also tend to develop LN earlier and have
poorer outcomes when compared to Caucasian individuals.
About LUPKYNIS
LUPKYNIS® is the first U.S. FDA- and EC-approved oral medicine
for the treatment of adult patients with active lupus nephritis
(LN). LUPKYNIS is a novel, structurally modified calcineurin
inhibitor (CNI) with a dual mechanism of action, acting as an
immunosuppressant through inhibition of T-cell activation and
cytokine production and promoting podocyte stability in the kidney.
The recommended starting dose of LUPKYNIS is three capsules twice
daily with no requirement for serum drug monitoring. Dose
modifications can be made based on Aurinia’s proprietary
personalized eGFR-based dosing protocol. Boxed Warning, warnings,
and precautions for LUPKYNIS are consistent with those of other
CNI-immunosuppressive treatments.
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical
company focused on delivering therapies to treat targeted patient
populations that are impacted by serious diseases with a high unmet
medical need. In January 2021, the Company introduced LUPKYNIS®
(voclosporin), the first FDA-approved and EC-approved oral therapy
dedicated for the treatment of adult patients with active lupus
nephritis. The Company’s head office is in Victoria, British
Columbia, its U.S. commercial office is in Rockville, Maryland. The
Company focuses its development efforts globally.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS
LUPKYNIS is indicated in combination with a background
immunosuppressive therapy regimen for the treatment of adult
patients with active LN. Limitations of Use: Safety and efficacy of
LUPKYNIS have not been established in combination with
cyclophosphamide. Use of LUPKYNIS is not recommended in this
situation.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing malignancies and serious
infections with LUPKYNIS or other immunosuppressants that may lead
to hospitalization or death.
CONTRAINDICATIONS
LUPKYNIS is contraindicated in patients taking strong CYP3A4
inhibitors because of the increased risk of acute and/or chronic
nephrotoxicity, and in patients who have had a serious/severe
hypersensitivity reaction to LUPKYNIS or its excipients.
WARNINGS AND PRECAUTIONS
Lymphoma and Other Malignancies: Immunosuppressants, including
LUPKYNIS, increase the risk of developing lymphomas and other
malignancies, particularly of the skin. The risk appears to be
related to increasing doses and duration of immunosuppression
rather than to the use of any specific agent.
Serious Infections: Immunosuppressants, including LUPKYNIS,
increase the risk of developing bacterial, viral, fungal, and
protozoal infections (including opportunistic infections), which
may lead to serious, including fatal, outcomes.
Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute
and/or chronic nephrotoxicity. The risk is increased when CNIs are
concomitantly administered with drugs associated with
nephrotoxicity.
Hypertension: Hypertension is a common adverse reaction of
LUPKYNIS therapy and may require antihypertensive therapy.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum
of neurotoxicities: severe include posterior reversible
encephalopathy syndrome (PRES), delirium, seizure, and coma; others
include tremor, paresthesia, headache, and changes in mental status
and/or motor and sensory functions.
Hyperkalemia: Hyperkalemia, which may be serious and require
treatment, has been reported with CNIs, including LUPKYNIS.
Concomitant use of agents associated with hyperkalemia may increase
the risk for hyperkalemia.
QTc Prolongation: LUPKYNIS prolongs the QTc interval in a
dose-dependent manner when dosed higher than the recommended lupus
nephritis therapeutic dose. The use of LUPKYNIS in combination with
other drugs that are known to prolong QTc may result in clinically
significant QT prolongation.
Immunizations: Avoid the use of live attenuated vaccines during
treatment with LUPKYNIS. Inactivated vaccines noted to be safe for
administration may not be sufficiently immunogenic during treatment
with LUPKYNIS.
Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA)
have been reported in patients treated with another CNI
immunosuppressant. If PRCA is diagnosed, consider discontinuation
of LUPKYNIS.
Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and
strong CYP3A4 inhibitors or with strong or moderate CYP3A4
inducers. Reduce LUPKYNIS dosage when co-administered with moderate
CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with
narrow therapeutic windows when co-administered.
ADVERSE REACTIONS
The most common adverse reactions (>3%) were glomerular
filtration rate decreased, hypertension, diarrhea, headache,
anemia, cough, urinary tract infection, abdominal pain upper,
dyspepsia, alopecia, renal impairment, abdominal pain, mouth
ulceration, fatigue, tremor, acute kidney injury, and decreased
appetite.
SPECIFIC POPULATIONS
Pregnancy/Lactation: May cause fetal harm. Advise not to
breastfeed.
Renal Impairment: Not recommended in patients with baseline eGFR
≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal
impairment: Reduce LUPKYNIS dose.
Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose.
Severe hepatic impairment: Avoid LUPKYNIS use.
Please see Prescribing Information, including Boxed Warning, and
Medication Guide for LUPKYNIS.
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